(3-chloro-2-hydroxypropyl)trimethylammonium chloride

Endpoint summary

Description of key information

CHPTAC (65%) was tested negative for skin and eye irritation properties in tests conducted according to OECD 404 and OECD 405.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

Cited as Directive 84/449/EEC, B.4

GLP compliance:

not specified

Remarks:

RAR, 2008 and IUCLID indicate GLP compliance, the study report does not.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hants, UK
- Age at study initiation: 11-12 wk
- Weight at study initiation: 2.4-2.7 kg
- Housing: 1/metal cage with perforated floor
- Diet: standard diet ad libitum
- Water: drinking water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx 19
- Humidity (%): 3-=70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 h/12 h


IN-LIFE DATES: From: To:

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL CHPTAC 65 % (as supplied)

Duration of treatment / exposure:

4 h

Observation period:

4 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm2
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 30 mins, days 2, 3, 4

Score:

0

Reversibility:

other: not applicable

Remarks on result:

other: 4-h exposure

Irritant / corrosive response data:

Not irritating

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

A guideline study found the test material (65% aqueous CHPTAC) to be non-irritant when in semi-occluded contact with rabbit skin for 4 h.

Executive summary:

 In a study conducted according to EU guideline, three New Zealand White rabbits received a 0.5ml dose of 65% CHPTAC in water to a shaved region in the dorso-lumbar area. The test substance was applied to an area of 2.5cm2. The patch was semi-occluded with an adhesive dressing for 4 hours. After the removal of the semi-occlusive dressing the application area was washed. The skin was examined 30 minutes after the removal of the patches and on days 2,3 and 4. The scores were zero at all time points. The substance is not irritating to rabbit skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Buckmasters, Henham, Herts, UK
- Age at study initiation: 20-24 wk
- Weight at study initiation: 2.2-3.1 kg
- Housing: 1/metal cage with perforated base
- Diet: standard diet ad libitum
- Water: drinking water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Vehicle:

unchanged (no vehicle)

Controls:

other: other eye serves as control

Amount / concentration applied:

Concentration: 65%
Amount applied: 0.1 mL

Duration of treatment / exposure:

examination after 1 h

Observation period (in vivo):

Examined at 1 h and 1, 2, 3, 4 and 7 days after instillation

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand torch

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

All symptoms were fully reversible within 96 hours.

Cornea: 0, 24, 72 h, 48 h: 1 animal: 1, 2 animals: 0,  Iris:
0 (3 animals, 24, 48, 72 h), 
Conjunctiva redness: 24 h: 2 (2 animals), 1 (1 animal)
                     48 h: 2 (3 animals)
                     72 h: 1 (3 animals)
After 4 and 7 days: 0 (3 animals).
Conjunctiva chemosis: 24 h: 2 (1 animal), 1 (2 animals)
                      48 h: 1 (3 animals)
                      72 h: 1 (2 animals), 0 (1 animal)
After 4 and 7 days: 0 (3 animals).

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

A reliable study, conducted according to OECD 405 and GLP, reported transient irritation, particularly of the conjunctiva, from a 65% aqueous solution of CHPTAC, that had resolved by 96 h. The scores would not meet EU criteria for classification.

Executive summary:

In a primary eye irritation study (OECD 405), 0.1 mL of CHPTAC (65%) was instilled into the conjunctival sac of one eye of each of three young adult New Zealand White rabbits. Animals were observed for 7 days. Irritation was scored by the method of Draize. Only very mild conjunctival reactions were observed, which were fully reversible within 96 hours. In this study, the test item is not an eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The key skin irritation study (Shell, 1987) was chosen from six studies, generating a similar classification, as the most recent study. The key study was of reliability 2 and the supporting studies comprised one of reliability 2, three of reliability 3 (reliable with restrictions; an absence of GLP) and one of reliability 4 (not assignable; very limited reports).

The key eye irritation/corrosion study was identified from seven giving broadly similar findings as the most recent study. The key study was of reliability 2. Supporting studies (reliability 2,3 and 4), indicated that the test material (55% or 60% CHPTAC or unspecified) was either slightly irritant or non-irritant. One study (QUAS048, reliability 2) produced results that were judged at the time to indicate a non-irritant material . The balance of findings from other studies (many of good quality) are that the test material (up to 65% CHPTAC, where specified) would not be classified as an eye irritant.

In the case of skin and eye irritation, it is not possible from the data identified to determine what the effect of the pure (100%) material might be.

Justification for classification or non-classification

Based on the available data, no classification for CHPTAC (65%) is warranted for skin and eye irritation.

In the case of skin and eye irritation, it is not possible from the data identified to determine what the effect of the pure (100%) material might be.